Full Text AR-96-002
 
SPECIALIZED CENTERS OF RESEARCH (SCORs) IN OSTEOPOROSIS, RHEUMATOID
ARTHRITIS AND SCLERODERMA
 
NIH Guide, Volume 25, Number 12, April 19, 1996
 
RFA:  AR-96-002
 
P.T. 34

Keywords: 
  07155031 
  07005050 
  Arthritis 
  Skin Diseases 
  Rheumatic Diseases 

 
National Institute of Arthritis and Musculoskeletal and Skin Diseases
 
Letter of Intent Receipt Date:  November 1, 1996
Application Receipt Date:  February 12, 1997
 
PURPOSE
 
The National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS) invites applications for Specialized Centers of
Research (SCORs) in the following disease areas: osteoporosis,
rheumatoid arthritis, and scleroderma.  A SCOR should foster a
coordinated research effort that strongly emphasizes basic
disciplines, but also involves significant interaction between basic
research and clinical investigations.  A SCOR is envisioned as a
national resource associated with one or more major medical complexes
and dedicated to working with the NIAMS in furthering the research
effort to translate basic research to clinical application.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This Request
for Applications (RFA), Specialized Center of Research (SCOR), is
related to the priority area of chronic disabling conditions.
Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report:  Stock No. 017-001-00474-0 or Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic for-profit and non-profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and
eligible agencies of the Federal government.  An established clinical
and research program in the disease area should be present.  Foreign
organizations are not eligible. International collaborations in
domestic applications will only be accepted if the resources are
clearly shown to be unavailable in the United States.  Applications
from racial/ethnic minority individuals and women and persons with
disabilities are encouraged.
 
MECHANISM OF SUPPORT
 
Support of this program will be through the NIH specialized center
(P50) award.  Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the
applicant.  Awards will be administered under PHS grants policy as
stated in the PHS Grants Policy Statement.
 
This RFA is a one-time solicitation for these disease areas.  A
separate RFA (AR-96-003) is directed to osteoarthritis and systemic
lupus erythematosus.  The total requested project period for an
application submitted in response to this RFA may not exceed four
years.  The anticipated award dates are September 1997 through April
1998.
 
FUNDS AVAILABLE
 
The NIAMS intends to fund up to nine SCORs in FY 1997 and 1998 in the
scientific areas covered by this RFA and RFA AR-96-003.  Funding is
subject to the availability of resources and receipt of sufficiently
meritorious applications.  Nine competing continuation applications
are anticipated in response to these RFAs.  The anticipated awards
are for four years and are subject to the availability of
appropriated funds.  The estimated funds (total costs) available for
the first year of support of these centers are $10 million per year.
The direct costs requested cannot exceed $750,000 (excluding indirect
costs of subcontracts) each year.
 
RESEARCH OBJECTIVES
 
The objective of the SCOR program is to expedite development and
application of new knowledge to a disease area, to learn more about
the etiology of these diseases, and to foster improved approaches to
treatment and/or prevention.  A SCOR consists of at least three
individual, but interrelated, research projects, each with high
scientific merit and clear research objectives and, in the aggregate,
devoted to a specific major health area.  Each SCOR should provide a
multidisciplinary approach utilizing both laboratory and clinical
research to focus on a particular health problem and provide for a
mutually supportive interaction between basic scientists and clinical
investigators.
 
Clinical research  is defined as patient oriented clinical research
conducted with human subjects, or on material of human origin (such
as tissue specimens and cognitive phenomena) for which an
investigator or colleague directly interacts with human subjects in
an outpatient or inpatient setting to clarify a problem in human
physiology, pathophysiology, or disease.
 
Although research programs will vary at each institution according to
local expertise, interests, and resources, each SCOR should have a
central theme related to the disease area to which individual
projects relate and which serves as an integrating force.  Emphasis
in proposed projects should be on development of innovative
approaches, elaboration of new and significant hypotheses, and
generation of improved strategies for approaching current issues
relating to the disease area addressed.
 
Funding may also be requested for one or more core resources.  A core
is defined as a resource shared by multiple investigators that
enhances research productivity and increases the functional capacity
of the SCOR.  Ongoing projects may be absorbed into the SCOR if their
original funding source is relinquished.
 
Support for large clinical trials or for applications that contain
exclusively clinical or exclusively basic studies will not be
provided within this SCOR program.
 
Applicants from institutions which have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
Resources may wish to identify the GCRC as a resource for conducting
the proposed research.  Details of the interactions of the SCOR staff
with the GCRC staff and research personnel may be provided in a
statement describing the collaborative linkages being developed.  A
letter of agreement from the GCRC Program Director must be included
with the application.
 
SPECIAL REQUIREMENTS
 
The director and co-director should budget for an annual one-day
meeting in Bethesda, MD with NIAMS staff.  The director should be
prepared to devote at least 15 percent effort as the director and 20
percent effort as a project PI.  Each project and core PI should be
prepared to devote at least 20 percent effort.
 
To be funded, a SCOR must include at least three highly meritorious
projects approved for four years.  One of these must have the SCOR
director as the principal investigator, and the highly meritorious
projects must include both basic and clinical research.
 
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS
 
It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990. The new policy contains some
provisions that are substantially different from the 1990 policies.
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.
 
Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by November 1, 1996, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to
which the application may be submitted.  Although a letter of intent
is not required, is not binding, and does not enter into the review
of subsequent applications, the information that it contains allows
NIAMS staff to estimate the potential review workload and to avoid
conflict of interest in the selection of reviewers.  The letter of
intent is to be sent to Dr. Julia B. Freeman at the address listed
under INQUIRIES.
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  Applications kits are available at
most institutional offices of sponsored research and may be obtained
from the Grants Information Office, Office of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714,
email:  ASKNIH@odrockm1.od.nih.gov.
 
Special guidelines have been developed for the SCOR program in NIAMS.
These guidelines should be used in assembling the application. See
INQUIRIES for obtaining a copy of these guidelines.
 
The RFA label available in the PHS 398 (rev. 5/95) application form
must be affixed to the bottom of the face page of the application.
Failure to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review. In addition, the RFA title, "Specialized Center of
Research (SCOR) in [add disease]", and number, "AR-96-002" must be
typed on line 2 of the face page of the application form and the YES
box must be marked.
 
Submit a signed, typewritten original of the application, including
the Checklist, and three signed photocopies of the application in one
package to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)
 
At the time of submission, send two additional copies of the
application to:
 
Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Natcher Building, Room 5AS.25U - MSC 6500
Bethesda, MD  20892-6500
Bethesda, MD  20814 (for express/courier service)
 
Applications must be received by February 12, 1997.  If an
application is received after the specified date, it will be returned
to the applicant without review.  The Division of Research Grants
(DRG) will not accept any application in response to this RFA that is
essentially the same as one currently pending initial review, unless
the applicant withdraws the pending application.  The DRG will not
accept any application that is essentially the same as one already
reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications
must include an introduction addressing the previous critique.
 
REVIEW CONSIDERATIONS
 
Applications for SCORs will be first screened for completeness by DRG
and responsiveness by NIAMS program staff.  Incomplete applications
will be returned to the application without further consideration.
In addition, if program staff find that the application is not
responsive to the RFA, it will be returned without further
consideration.
 
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIAMS in accordance with the NIH peer
review procedures.  As part of the initial merit review, all
applications will receive a written critique and undergo a process in
which only those application deemed to have the highest scientific
merit, generally the top half of applications under review, will be
discussed, assigned a priority score, and receive a second level
review by the National Advisory Council for NIAMS.
 
If the project from the SCOR director is not recommended for further
consideration during the review for scientific merit, the entire SCOR
application will not be reviewed further.  If all the clinical
research projects in a SCOR application are not recommended for
further consideration, the SCOR application will not be further
reviewed.
 
Major factors to be considered in evaluation of applications will
include:
 
1.  How the proposed SCOR combines basic and clinical research into
the scientific goals and research theme;
2.  If a competing continuation application, the quality and
significance of the progress made in the previous funding period;
3.  Scientific merit of each proposed project, including originality
and feasibility of the project and adequacy of the experimental
design;
4.  Scientific merit of combining the component parts into a SCOR;
5.  Technical merit and justification of each core unit;
6.  Competence of the investigators to accomplish the proposed
research goals, their commitment, and the time they will devote to
the research program;
7.  Adequacy of facilities to perform the proposed research,
including laboratory and clinical facilities, instrumentation, and
data management systems, when needed;
8.  Adequacy of plans for interaction among investigators, and the
integration of the various projects and core units;
9.  Qualifications, experience and commitment of the SCOR Director
and his/her ability to devote time and effort to provide effective
leadership;
10.  Scientific and administrative structure, including internal and
external procedures for monitoring and evaluating the proposed
research and for providing ongoing quality control and scientific
review;
11.  Institutional commitment to the program, and the appropriateness
of resources and policies for the administration of a SCOR;
12.  Adequacy of plans to include both genders and minorities and
their subgroups as appropriate for the scientific goals of the
research.  Plans for the recruitment and retention of subjects will
also be evaluated.
 
The appropriateness of the budget for the proposed program and its
individual components will be considered independently of the factors
indicated above.
 
AWARD CRITERIA
 
The anticipated award dates will be as early as September 1, 1997,
and as late as April 1, 1998. The primary factors determining the
award will be the priority score, the overall balance of meritorious
projects (clinical and basic research) within the application
relative to the disease area, and the availability of funds.  Since
the NIAMS is interested in funding only the best research, individual
projects or cores of lesser quality may not be funded, even if
approved, under the "umbrella" of the SCOR mechanism.
 
INQUIRIES
 
Inquiries are encouraged.  The opportunity to clarify any issues or
questions from potential applicants is welcome.  Inquiries regarding
programmatic issues and letters of intent may be directed to:
 
Dr. Julia B. Freeman
Centers Program, EP
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Natcher Building, Room 5AS.19F -  MSC 6500
Bethesda, MD  20892-6500
Bethesda, MD  20814 (for express/courier service)
Telephone:  (301) 594-5052
FAX:  (301) 480-4543
Email:  freemanj@ep.niams.nih.gov
 
Copies of the guidelines for the SCOR program may be obtained from:
 
NIAMS Clearinghouse
1 AMS Circle
Bethesda, MD  20892-3675
Telephone: (301) 495-4484
FAX: (301) 587-4352
 
Direct inquiries regarding fiscal matters to:
 
Sally A. Nichols
Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Natcher Building Room 5AS.49F - MSC 6500
Bethesda, MD  20892-6500
Telephone: (301) 594-3535
FAX: (301) 480-5450
Email:  nicholss@ep.niams.nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.846, Arthritis, Musculoskeletal and Skin Diseases
Research.  Awards will be made under the authority of the Public
Health Service Act, Title III, Section 301 (Public Law 410, 78th
Congress, as amended, 42 USC 241) and administered under PHS grant
policies and Federal regulations 42 CFR Part 52 and 45 CFR Part 74.
This program is not subject to intergovernmental review requirements
of Executive Order 12372 or Health Systems Agency review.
 
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.
 
.

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